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临床试验/NCT04483908
NCT04483908已完成不适用

COVID-19 in Baselland: Investigation and Validation of Serological Diagnostic Assays and Epidemiological Study of Sars-CoV-2 Specific Antibody Responses (SERO-BL-COVID-19)

University Hospital, Basel, Switzerland1 个研究点 分布在 1 个国家目标入组 477 人开始时间: 2020年4月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
477
试验地点
1
主要终点
Qualitative method validation (yes/ no)

研究概览

简要总结

The study is to investigate the antibody response in the blood and saliva of people with a known COVID-19 infection in the canton of Baselland.

详细描述

This study is to analyse the antibody response in the blood and saliva of people with a known COVID-19 infection in the canton of Baselland.

The study aims to validate strategies to measure antibody levels with minimal intervention and to explore the antibody response and technical capacity for said measurement. The study will collect the minimally necessary samples to deduce a strategy for serum or saliva surveillance of the population of the canton Baselland. To achieve this, the study is designed to address the following points:

  • determine specificity, sensitivity and general utility of point of care (POC) and ELISA tests to deduce a strategy for serum surveillance of the population of the canton Baselland
  • especially validate different POC kits in regard of their use for continuous surveillance
  • gain an understanding of seroconversion and antibody levels of patients and survivors
  • gain an understanding of the individual antibody and T-cell repertoire of patients and survivors
  • study whether patterns of convergent antibody evolution is generated in the surviving population or whether the diseases survivors generated an antibody pool recognizing a specific epitope
  • develop the technology to correlate blood antibody levels with levels detected in the saliva
  • develop high throughput technologies for the precise detection of immune cell Repertoire and binding epitopes

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • tested positive for COVID-19 in Baselland
  • tested negative for COVID-19 in Baselland. Specifically, needed to show symptoms to be able to deduce cross reactivities.

排除标准

  • continuous steroid therapy / chemotherapy / immunsuppressiva
  • subject is treated for cancer
  • severe autoimmune disease

结局指标

主要结局

Qualitative method validation (yes/ no)

时间窗: at baseline

Qualitative method validation: qualitative result of the ELISA (Patient does / does not have immunity) as the gold standard compared to the POC using univariate measures to derive sensitivity and specificity of the POC.

Quantitative method validation (antibody concentrations)

时间窗: at baseline

Quantitative method validation: antibody concentration from the ELISA are related to the dichotomous result from POC.

次要结局

  • Immune cell repertoire sequencing(at baseline)

研究者

发起方
University Hospital, Basel, Switzerland
申办方类型
Other
责任方
Sponsor

研究点 (1)

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